Siemens Healthineers Expands Atellica Analyzer Capillary Testing With Industry-Leading Menu Covering 24 Assays
Siemens Healthineers has announced a significant expansion of capillary testing capabilities across its Atellica laboratory analyzer portfolio, providing clinical laboratories with broader options for performing blood tests using smaller-volume samples. The company has received CE marking for 24 capillary blood testing claims on the Atellica CH, Atellica IM and Atellica CI Analyzers.
The development expands the range of tests that laboratories can perform using capillary blood samples and is intended to support greater flexibility in patient testing. Capillary blood collection is commonly performed through a finger prick or heel stick rather than a conventional venipuncture, in which a needle is inserted into a vein to obtain a blood sample.
For laboratories, the expanded capillary testing menu could help address a variety of patient and operational needs. The available claims cover several common areas of laboratory testing, including assays associated with comprehensive metabolic panels, lipid testing, thyroid testing, Vitamin D and HbA1c.
The company describes the expanded menu as an important advancement for core laboratory testing because it allows laboratories to use the same established Atellica systems for a broader range of sample collection methods.
“Offering a capillary test menu expands the testing that can be done in the core lab to reach more patients and support more testing needs – all with the same systems they already trust,” said Sharon Bracken, head of Diagnostics at Siemens Healthineers. “Our efforts to expand capillary claims across our assay menu build upon our broader vision to make testing more accessible, efficient, and patient-friendly.”
Expanding the Role of Capillary Testing in the Core Laboratory
Traditionally, many laboratory tests have relied on venous blood collection. Venipuncture remains a widely used method for obtaining blood samples, particularly in hospitals, outpatient laboratories and other clinical settings.
However, collecting blood from a vein can present challenges for certain patients. Some individuals have difficult-to-access veins, while others may have limited blood volume or conditions that make repeated venipuncture more difficult.
Capillary blood collection offers an alternative approach in appropriate situations. The process generally requires a smaller sample volume and can be performed through a finger prick or heel stick.
The expanded capillary testing capabilities of the Atellica analyzers are designed to allow laboratories to perform additional testing using this type of sample.
The significance of the CE marking lies in the availability of validated, on-label capillary performance data for the 24 assays. This provides laboratories with manufacturer-supported information regarding the performance of the assays when capillary samples are used.
Laboratory testing methods can influence sample quality and test results. Differences in collection techniques, sample volume and handling may affect the performance of an assay. As a result, laboratories that want to use capillary samples for tests that were traditionally performed using venous blood may need to conduct additional validation activities.
The availability of specific capillary testing claims can help simplify that process by providing validated performance information for the intended use.
Why Validated Capillary Claims Matter
The use of capillary blood in laboratory testing requires careful consideration of sample collection and analytical performance.
Blood collected through a finger prick or heel stick may have different characteristics from blood collected through venipuncture. The amount of blood available may also be smaller, and the collection process can be influenced by factors such as technique and patient condition.
For these reasons, laboratories need confidence that test results generated from capillary samples meet appropriate performance expectations.
Capillary claims provide validated information that supports the use of the specified assays with capillary blood samples. This can give laboratories greater clarity when evaluating whether to incorporate capillary testing into their workflows.
Without manufacturer-provided claims, laboratories may need to take additional steps to independently assess and validate the performance of a particular testing method.
The availability of 24 CE-marked capillary claims on the Atellica CH, IM and CI Analyzers is therefore intended to reduce barriers to broader adoption of capillary testing in the core laboratory.
The expanded menu also enables laboratories to consider capillary testing as part of their broader strategy for improving access to diagnostic services.
Covering Common Laboratory Testing Needs
The 24 assays included in the capillary testing menu span multiple areas of routine laboratory testing.
The menu includes important tests associated with comprehensive metabolic panels, which are commonly used to evaluate multiple aspects of a patient’s health. The expanded capabilities also include lipid testing, thyroid assays, Vitamin D testing and HbA1c.
These testing categories are relevant across a wide range of clinical settings.
Metabolic testing can help healthcare professionals assess various biological functions and monitor patients with chronic conditions. Lipid testing is widely used in cardiovascular risk assessment and monitoring. Thyroid testing plays an important role in evaluating thyroid function, while Vitamin D testing may be used in appropriate clinical situations to assess vitamin status.
HbA1c testing is an important tool in diabetes care and provides information about average blood glucose levels over a period of time.
By supporting capillary testing across these categories, Siemens Healthineers is providing laboratories with additional flexibility in how they collect samples and deliver testing services.
The use of a common analyzer platform may also help simplify laboratory operations. Rather than requiring a separate testing system for certain capillary samples, laboratories using Atellica analyzers may be able to integrate the approved capillary testing capabilities into their existing workflows, subject to applicable requirements and laboratory procedures.
Addressing Patient Access Challenges
Capillary testing may be particularly useful for patients who experience difficulties with conventional blood collection.
Some patients have veins that are difficult to access, making venipuncture more challenging. Repeated attempts to obtain a venous sample can cause discomfort and may require additional time and resources.
Patients with low blood volume may also benefit from testing approaches that require smaller samples when clinically appropriate.
Capillary testing may also provide an alternative for patients who experience significant anxiety related to needles. Individuals with trypanophobia, or a fear of needles, may find conventional venipuncture particularly difficult.
For some patients with disabilities, venous blood collection can also present practical challenges.
The availability of capillary testing does not replace venipuncture in all situations. However, it can provide laboratories and healthcare providers with another option when appropriate for the patient and the test being performed.
This flexibility may become increasingly valuable as healthcare providers seek ways to make diagnostic testing more accessible and patient-friendly.
Supporting Laboratories Facing Operational Pressures
Clinical laboratories are also facing growing operational challenges. Staffing shortages, increasing test volumes and demand for faster turnaround times are placing pressure on laboratory systems.
At the same time, healthcare organizations are seeking ways to expand access to testing and serve patients in a wider range of settings.
Capillary testing may help laboratories respond to some of these challenges by creating additional options for sample collection.
A smaller sample requirement may be useful in settings where conventional blood collection is difficult. It can also support testing approaches designed around specific patient populations.
The integration of capillary testing into core laboratory analyzers may provide operational advantages for laboratories that already use the Atellica platform.
By expanding the number of assays with capillary claims, Siemens Healthineers is giving laboratories more opportunities to evaluate how capillary testing could fit into their existing workflows.
The company’s broader strategy is focused on making laboratory testing more efficient, accessible and adaptable to changing healthcare needs.
Capillary Testing in the United States
While the expanded 24-assay menu relates to CE-marked testing, Siemens Healthineers also offers capillary testing claims for four assays in the United States.
These include total protein, alanine aminotransferase, aspartate aminotransferase and triiodothyronine.
The company is pursuing additional capillary testing claims with the U.S. Food and Drug Administration, subject to regulatory review.
The effort reflects Siemens Healthineers’ broader strategy to expand capillary testing capabilities across its laboratory portfolio.
Regulatory approval is an important part of expanding the use of capillary testing in different markets. Requirements vary by jurisdiction, and manufacturers must obtain appropriate authorization for specific claims and intended uses.
As additional regulatory reviews progress, laboratories may eventually have access to a broader range of capillary testing options in the United States.
A Step Toward More Flexible Diagnostic Testing
The expansion of capillary testing on the Atellica CH, IM and CI Analyzers represents a broader shift toward greater flexibility in laboratory diagnostics.
Healthcare delivery is increasingly moving toward models that seek to bring testing closer to patients and adapt procedures to individual needs. Although core laboratories remain central to high-volume diagnostic testing, the ability to use different sample collection approaches can help laboratories respond to a wider range of patient requirements.
Capillary testing can be particularly relevant in situations where venous blood collection is difficult or impractical.
The availability of validated claims also helps provide laboratories with greater confidence when evaluating the use of capillary samples.
For laboratory professionals, the expanded menu may support more consistent approaches to capillary testing and reduce the need to develop independent validation strategies for each assay.
Improving the Patient Experience
The patient experience is another important consideration in the development of capillary testing.
Traditional blood draws can be stressful or uncomfortable for some individuals. A finger prick or heel stick may provide a simpler collection experience in appropriate circumstances.
This may be particularly relevant for patients who require repeated monitoring or those who have difficulty with venous access.
By expanding the number of tests that can be performed using capillary blood, laboratories may be able to offer more patient-friendly collection options.
The availability of such options could also support testing among individuals who might otherwise delay or avoid blood testing because of concerns about venipuncture.
Siemens Healthineers’ expansion of capillary testing on the Atellica analyzer portfolio highlights the growing importance of flexible sample collection in modern laboratory medicine.
With CE marking for 24 capillary blood testing claims across the Atellica CH, IM and CI Analyzers, laboratories have access to a broader range of testing capabilities that can support diverse patient needs.
The menu includes assays relevant to metabolic, lipid, thyroid, Vitamin D and HbA1c testing, covering several common areas of clinical laboratory medicine.
For laboratories, the availability of validated capillary claims may help simplify implementation and provide greater confidence in analytical performance. For patients, capillary testing may offer a more accessible alternative to conventional venipuncture in appropriate situations.
The company is also pursuing additional capillary testing claims with the FDA in the United States, subject to regulatory review. This suggests that the expansion of capillary testing capabilities may continue as regulatory pathways develop.
As laboratories face growing demand, staffing pressures and the need to improve patient access, alternative approaches to blood collection may become increasingly important.
The expansion of capillary testing on the Atellica platform is part of a broader effort to make diagnostic testing more flexible, efficient and patient-centered. By enabling more assays to be performed using capillary blood samples on established core laboratory analyzers, Siemens Healthineers is helping laboratories explore new ways to meet changing clinical and patient needs.
Ultimately, the development demonstrates how advances in laboratory technology can extend beyond analyzer performance alone. The way blood is collected can also influence access, convenience and the patient experience. By expanding validated capillary testing capabilities, Siemens Healthineers is seeking to give laboratories more choices while supporting the continued evolution of modern diagnostic testing.
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